Coronary/Structural Heart

Orchestra BioMed Announces Publication of AVIM Therapy Clinical Data in JACC: Advances Demonstrating Potential to Improve Cardiac Function in Patients with Hypertension and Diastolic Dysfunction

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Echocardiographic data analysis demonstrated favorable impact of atrioventricular interval modulation (“AVIM”) therapy on MODERATO II study patients with diastolic dysfunction, a key component in the development of heart failure with preserved ejection fraction (“HFpEF”)Hypertension is the leading cause of diastolic dysfunction and the most common comorbidity in older patients indicated for a pacemaker NEW HOPE, Pa., Aug. 14, 2025 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced the publication of clinical data in JACC: Advances demonstrating that AVIM therapy significantly improved cardiac function in patients with hypertension and diastolic dysfunction (“DD”), key contributors to the development of HFpEF. The publication, titled “Effects of AtrioVentricular Interval Modulation (AVIM) Therapy in Subjects with Hypertension and Diastolic Dysfunction,” reports findings from a retrospective treatment-blinded analysis of MODERATO II patients. The analysis demonstrated that AVIM therapy significantly reduced systolic blood pressure (SBP) and improved echocardiographic markers of DD, a key contributor to HFpEF – a common comorbidity in patients with isolated systolic hypertension (ISH). These results were previously presented in a late-breaking session at the 2025 Technology and Heart Failure Therapeutics Meeting and are now published in JACC: Advances. Key findings: AVIM therapy significantly reduced both office and ambulatory SBP in patients with DD over 6 months, with office SBP reduced by 12.1±12.8 mmHg and ambulatory SBP by 8.3±9.7 mmHg (both p

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Analytics For Life Completes Clinical Study of Non-Invasive Point-of-Care Test for Elevated Pulmonary Capillary Wedge Pressure (PCWP) Using Machine Learning

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Study achieves primary sensitivity endpoint, advancing diagnostics for heart failure with preserved ejection fraction (HFpEF) and pulmonary hypertension (PH)Results build on data previously presented at ACC.25 in March 2025 TORONTO and BETHESDA, Md., Aug. 14, 2025 (GLOBE NEWSWIRE) — Analytics For Life, in collaboration with its U.S. commercial partner CorVista Health, today announced the successful completion of the clinical study evaluating a machine learning-based algorithm for non-invasively identifying patients with elevated pulmonary capillary wedge pressure (PCWP) – a key indicator of both heart failure with preserved ejection fraction (HFpEF) and heart failure with reduced ejection fraction (HFrEF). The study met its primary endpoint for sensitivity, marking a significant milestone in the advancement in point-of-care diagnostics for heart failure patients. The results of the study will be submitted for peer-reviewed publication and presented at an upcoming scientific conference. Currently, PCWP is measured through an invasive right heart catheterization (iRHC) procedure, typically performed by a cardiologist, pulmonologist or intensivist. The CorVista capture device collects non-invasive signals for 3.5 minutes in patients at rest, potentially providing a novel method to aid in the assessment of patients being evaluated for pulmonary hypertension or heart failure. “Reaching our primary endpoint in sensitivity is a testament to the dedication of our team to pushing the boundaries of cardiovascular diagnostics. Our ability to deliver non-invasive, rapid assessment of PCWP could be a game-changer, making early detection of HFpEF, HFrEF and PH subtypes more accessible for patients,” said Charles R. Bridges, M.D., Sc.D., Executive Vice President and Chief Scientific Officer, Analytics for Life and CorVista Health. “With the clinical study now complete, we plan to initiate dialogue with regulatory agencies in preparation for the next phase of development.” Adrian Lam, President and Chief Executive Officer, CorVista Health, added, “This milestone demonstrates the power of our rapid, point-of-care solution and represents an important step toward expanding the clinical utility of the CorVista System. Adding PCWP and heart failure capabilities would allow our system to provide diagnostic support to more than 70% of all people with symptomatic cardiovascular disease – itself the leading cause of death worldwide. As we pursue a PCWP add-on, our goal is to bring advanced diagnostic accuracy into the primary care setting, enabling faster and more accurate treatment decisions while reducing the overall cost of care.” HFpEF accounts for over 50% of all heart failure cases and carries the highest rates of morbidity and mortality. Underdiagnosis of HFpEF remains one of the greatest unmet needs in cardiovascular medicine today, contributing an estimated $25 billion in direct costs to the U.S. healthcare system each year. Pulmonary hypertension, similarly underdiagnosed, requires accurate subtype classification to guide life-saving, guideline-directed therapy. The proposed PCWP add-on represents a major advancement in cardiology with far-reaching implications for early diagnosis, equitable care, and cost reduction. The CorVista System Add-On for elevated PCWP is currently an investigational device, limited by U.S. federal law to investigational use and not commercially available. About CorVista System® Developed by Analytics For Life and commercialized in the U.S. by CorVista Health, the CorVista System is a point-of-care digital health solution that detects multiple heart conditions in a single, non-invasive test. The system uses machine learned algorithms to quickly analyze heart signals and detect issues like blocked arteries or elevated pulmonary artery pressure—all in under 30 minutes, allowing clinicians to interpret results and guide treatment decisions in a single visit. The system received clearance from the U.S. Food and Drug Administration (FDA) for coronary artery disease in September 2023 and Pulmonary Hypertension in April 2024, with additional indications, including heart failure, in active development. In 2022, the CorVista System’s PH indication was awarded an FDA Breakthrough Device Designation—marking the first major advancement in PH diagnostics in over 40 years and setting a new standard for patient care. About Analytics For Life Analytics 4 Life stands at the forefront of digital health, dedicated to propelling next-generation technologies that revolutionize point-of-care diagnostics. Headquartered in Toronto, Canada, Analytics For Life specializes in pioneering non-invasive diagnostic solutions for cardiovascular diseases through the CorVista System®. The innovative CorVista System offers a non-invasive, point-of-care solution enabling physicians to assess symptomatic patients for cardiovascular disease without radiation, contrast agents, injections, fasting, or exercise. Spearheading its introduction in the United States is our exclusive commercial partner, CorVista Health. For more information on Analytics For Life, please visit: www.analytics4life.com About CorVista Health CorVista Health is on a mission to transform cardiovascular care with diagnostics that shorten the path from symptoms to diagnosis, empowering earlier treatment and better patient outcomes. We are dedicated to enabling more equitable care by providing access to immediately actionable, high-quality cardiovascular test results for previously underserved patient populations – with the goal of contributing to a future where everyone has timely access to life-saving cardiovascular care. For more information on CorVista Health, please visit: www.corvista.com Media Contact:media@corvista.com

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Orchestra BioMed Announces Rollout of FDA-Approved BACKBEAT Global Pivotal Study Protocol Update Significantly Expanding Patient Eligibility

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FDA-approved protocol update significantly expands patient eligibility criteria for the BACKBEAT global pivotal study (“BACKBEAT study”), resulting in an estimated more than 24-fold increase in the potentially eligible patient pool as compared to original study protocolExpanded eligibility criteria now include screening of any hypertensive patients who have received or are scheduled to receive a Medtronic Azure™ or Astra™ pacemaker, including device replacements NEW HOPE, Pa., Aug. 08, 2025 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced the roll out of a protocol update, approved by the U.S. Food and Drug Administration (“FDA”), that significantly expands patient eligibility criteria for enrollment of the BACKBEAT study evaluating AVIM therapy in pacemaker-indicated patients with uncontrolled hypertension despite the use of antihypertensive medications. Key updates to eligibility criteria now include patients with: Medtronic Astra or Azure dual-chamber pacemakers with sufficient battery life implanted for any reason;Medtronic Astra or Azure dual-chamber pacemakers that are first device implants or implanted to replace an existing pacemaker; andNew York Heart Association (“NYHA”) class I or class II symptomatic heart failure. Orchestra BioMed estimates that the BACKBEAT study protocol update increases the eligible potential patient pool at participating study centers by more than 24-fold as compared to the original protocol and supports the Company’s mid-2026 target for completion of enrollment. The Company initiated rollout of the updated protocol in the third quarter of 2025 with full implementation expected in the fourth quarter. “These expanded eligibility criteria significantly increase the pool of potentially eligible patients available for enrollment in the BACKBEAT study at participating study centers. They also better align the study patient population with the key characteristics of the FDA Breakthrough Device Designation for AVIM therapy, which we estimate represents a patient population of millions of U.S. patients who need better therapeutic options to manage elevated systolic blood pressure and the corresponding higher risk of heart attack, stroke, heart failure and other morbid and mortal events,” said David Hochman, Chairman and CEO of Orchestra BioMed. “We believe these updates reinforce the relevance and potential impact of the BACKBEAT study as well as better position us to complete the BACKBEAT study in a timely manner.” “Unlike traditional antihypertensive therapies, AVIM therapy has been designed specifically to address the needs of the older, higher risk hypertensive patients who often also need a pacemaker,” commented Andrea Russo, M.D., Academic Chief, Division of Cardiology, Director of Cardiac Electrophysiology and Arrhythmia Services, Cooper University Hospital, and Co-Principal Investigator of the BACKBEAT study. “The ability to activate AVIM therapy during the 10 to 12-year typical device lifecycle of a pacemaker reflects the practical and transformative potential of this therapy for this group of patients. With expanded patient eligibility criteria, the BACKBEAT study population will now better encompass a real-world population of older, pacemaker-indicated patients with uncontrolled hypertension and increased cardiovascular risk.” About Orchestra BioMedOrchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed’s lead product candidate is AVIM therapy for the treatment of uncontrolled hypertension, the leading risk factor for death worldwide. Orchestra BioMed is also developing Virtue SAB for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of AVIM therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease. The Company has received four Breakthrough Device Designations from the U.S. FDA across these two core programs, reflecting the significant potential of its technologies to address high unmet needs in cardiovascular care. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. References to Websites and Social Media Platforms References to information included on, or accessible through, websites and social media platforms do not constitute incorporation by reference of the information contained at or available through such websites or social media platforms, and you should not consider such information to be part of this press release. About AVIM Therapy AVIM therapy is an investigational therapy compatible with standard dual-chamber pacemakers designed to substantially and persistently lower blood pressure. It has been evaluated in pilot studies in patients with uncontrolled hypertension who are also indicated for a pacemaker. MODERATO II, a double-blind, randomized pilot study, showed that patients treated with AVIM therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. In addition to reducing blood pressure, clinical results using AVIM therapy demonstrate improvements in cardiac function and hemodynamics. The BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal study will evaluate the safety and efficacy of AVIM therapy in lowering blood pressure in patients who have systolic blood pressure above target despite anti-hypertensive medication and who are indicated for or have recently received a dual-chamber cardiac pacemaker. AVIM therapy has been granted Breakthrough Device Designation by the FDA by using cardiac physiologic pacing for the treatment of uncontrolled hypertension in patients who have preserved left ventricular systolic function and are at increased cardiovascular risk. Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the effect of study protocol on the potentially eligible patient pool, the timing of completion of enrollment for the BACKBEAT study, the timing of full implementation of updated study protocol, , the potential benefits of Breakthrough Device Designation, the potential of the Company’s technologies to address high unmet needs in cardiovascular care, realizing the clinical and commercial value of AVIM therapy and Virtue SAB, the potential safety and efficacy of the Company’s product candidates, and the ability of the Company’s partnerships to accelerate clinical development. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company’s commercial product candidates and ongoing regulation of the Company’s product candidates, if approved; the timing of, and the Company’s ability to achieve expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on March 31, 2025 and the risk factor discussed under the heading “Item 1A. Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, which was filed with the SEC on May 12, 2025. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law. Investor ContactSilas NewcombOrchestra BioMed Snewcomb@orchestrabiomed.com Media ContactKelsey Kirk-EllisOrchestra BioMedKkirkellis@orchestrabiomed.com

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BioCardia Reports Second Quarter 2025 Business Highlights and Financial Results

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SUNNYVALE, Calif., Aug. 11, 2025 (GLOBE NEWSWIRE) — BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported financial results for the second quarter of 2025 and filed its quarterly report on Form 10-Q for the three and six months ended June 30, 2025 with the Securities and Exchange Commission. The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights. Following management’s formal remarks, there will be a question-and-answer session. Recent Business Highlights CardiAMP® autologous cell therapy in ischemic heart failure of reduced ejection fraction (BCDA-01) Two-year results from the double-blind randomized placebo-controlled Phase 3 CardiAMP HF Trial of CardiAMP autologous minimally invasive cell therapy for the treatment of ischemic heart failure in patients with reduced ejection fraction (HFrEF) were presented as a late-breaking clinical trial at the American College of Cardiology’s Annual Scientific Sessions on March 30, 2025. For study subjects, all on stable guideline directed medical therapy, the CardiAMP HF treatment group had a lower incidence of both all cause death and non-fatal MACCE than the control group during the entire 24-month period of the CardiAMP HF study (p=0.17) and the composite endpoint of all cause death, non-fatal MACCE, and quality of life was statistically significant in the subgroup of patients with elevated NTproBNP (p =0.02).CardiAMP HF Trial data has been submitted to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and we have requested a meeting to receive advice to align with PMDA on the acceptability of the clinical data and positioning of the CardiAMP system for Japanese patients with heart failure. We anticipate an in-person consultation in the fourth quarter of 2025, the outcome of which could enable us to submit for approval of the CardiAMP system for market entry in Japan.We have reported parallel ongoing efforts towards requesting a meeting with the FDA on the approvability of the FDA Designated Breakthrough CardiAMP System based on this clinical data in the fourth quarter 2025.The confirmatory CardiAMP HF II phase 3 trial is underway in the United States, with four sites actively enrolling patients and additional sites being onboarded. This trial focuses on patients with active heart stress with a primary composite endpoint of all cause death, non-fatal MACCE, and quality of life achieved in CardiAMP HF (p=0.02). CardiAMP HF II includes using the cell population analysis at screening to define treatment doses, which enables more patients to be eligible for the therapy, and improvements to the Helix system, with the use of the FDA approved Morph DNA steerable platform. Medicare reimbursement for both treated and controlled patients under C9782 is currently $17,500, which helps offset the costs of this study and reported as a reduction in R&D expense. CardiAMP autologous cell therapy in chronic myocardial ischemic with refractory angina (BCDA-02) Results from the open-label roll-in cohort of patients having chronic myocardial ischemia with refractory angina to date have shown an average 107 second increase in exercise tolerance and an 82% average reduction in angina episodes at the primary six-month follow-up endpoint compared to before receiving the study treatment. The CardiAMP cell therapy procedure for chronic myocardial ischemia is also reimbursed by CMS under reimbursement code C9782, which covers both treated and controlled patients. The last roll-in cohort patient has reached this six-month primary endpoint, and we intend to prepare the primary results of this cohort for publication and presentation. CardiALLO allogeneic cell therapy in Ischemic Heart Failure (BCDA-03) The Investigational New Drug application (IND) for a Phase 1/2 trial to deliver our allogeneic MSC for the treatment of HFrEF follows our previous cosponsored TRIDENT and POSEIDON clinical trials enrolling 45 patients at dosages up to 100 million cells delivered with our Helix transendocardial catheter. The current trial includes a 3+3 roll-in dose escalation up to a dose of 200 million cells followed by a 30-patient randomized double-blind controlled study based on a recent IND amendment to right size the study for nondilutive funding opportunities which are under discussion. The low dose cohort of 20 million cells has been completed and there have been no treatment-emergent adverse events, arrhythmias, rejection, or allergic responses. The independent Data Safety Monitoring Board recommended that the study proceed as designed in April 2025 based on the 30-day data safety assessment from this cohort. Helix Biotherapeutic Delivery The Helix transendocardial biotherapeutic delivery system is a therapeutic-enabling platform for minimally invasive targeted delivery of biologic agents to the heart and underlies BCDA-01, 02, and 03 programs. We recently announced our intent to submit for approval of the Helix transendocardial system as a DeNovo 510(k) in the third quarter 2025. Intellectual Property The Company’s intellectual property portfolio was strengthened with the issuance of another patent this past quarter. In June, the Company announced that the that United States Patent Office has granted US patent No. 12,311,127 titled “Radial and Trans-endocardial Delivery Catheter.” The patent describes the Company’s minimally invasive interventional biotherapeutic delivery catheter systems to deliver biologic therapies to target sites in the heart. This minimally invasive delivery approach enables optimal, site-specific treatment, minimizes off-target toxicities, and avoids the need for surgical access to the heart. The allowed patent protects BioCardia’s helical needle-tipped catheter technology platform, which the scientific literature supports is the safest1 and most efficient2 approach for biotherapeutic delivery to the heart. “Heart failure remains a large, unmet need, impacting the lives of 56 million people worldwide, and we have made significant progress advancing our autologous CardiAMP cell therapy candidate intended to promote increased microvascular density and reduce fibrosis for a significant subgroup of these patients,” said BioCardia CEO Peter Altman, Ph.D. “Our active discussions on the approvability of the CardiAMP Cell Therapy System, as well the anticipated submission for approval of its dedicated Helix transendocardial biotherapeutic delivery catheter with even broader therapeutic impact have potential to be transformative for patients, physicians, and shareholders alike.” Second Quarter 2025 Financial Results: Research and development expenses increased to approximately $1.4 million for the three months ended June 2025 from approximately $0.8 million in the three months ended June 2024, and increased to approximately $2.9 million in the six months ended June 2025 from the six months ended June 2024, primarily due to closeout activities in the CardiAMP HF Trial and the beginning of enrollment in the CardiAMP HF II Trial.Selling, general and administrative expenses decreased to approximately $0.7 million in the three months ended June 2025 compared to approximately $0.9 million for the three months ended June 2024, primarily due to lower professional fees and share-based compensation expense. Selling, general and administrative expenses remained consistent at approximately $1.9 million in the six months ended June 2025, as compared to approximately $1.9 million in the six months ended June 2024.Our net loss was approximately $2.0 million for the three months ended June 2025, compared to approximately $1.6 million for the three months ended June 2024, and was approximately $4.8 million for the six months ended June 2025, compared to approximately $3.9 million for the six months ended June 2024. These increases were due primarily to the increased expenses associated with closeout activities in the CardiAMP HF Trial and the beginning of enrollment in the CardiAMP HF II Trial.Net cash used in operations for the three months ended June 2025 was approximately $1.6 million, as compared to approximately $1.3 million for the three months ended June 2024. Net cash used in operations for the six months ended June 2025 was approximately $3.3 million, as compared to approximately $2.8 million for the six months ended June 2024.Our cash balance on June 30, 2025, was approximately $980,000. During the period from July 1, 2025 to August 8, 2025, we sold an aggregate of 296,422 shares of common stock under our ATM program at an average price of $2.59 per share to total gross proceeds of $769,000. This brings our current cash balance to approximately $1.1 million and provides runway into October 2025. ANTICIPATED UPCOMING MILESTONES AND EVENTS: BCDA-01 CardiAMP Autologous Cell Therapy in Heart Failure (HF) CardiAMP HF manuscript – Q4 2025CardiAMP HF Japan PMDA Clinical Review – Q4 2025CardiAMP HF FDA meetings on approvability based on subgroup and safety – Q4 2025CardiAMP HF II Enrollment – Ongoing            BCDA-02 CardiAMP Autologous Cell Therapy in Chronic Myocardial Ischemia CardiAMP CMI Top line Data Rollin Cohort – Q4 2025 BCDA-03 CardiALLO Allogeneic MSC Cell Therapy in Heart Failure CardiALLO HF Nondilutive Funding – Q1 2026 Helix Biotherapeutic Delivery System Helix biotherapeutic delivery FDA Submission for Approval – Q3 2025 About BioCardia BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLOTM allogeneic cell therapies are the Company’s biotherapeutic platforms with three cardiac clinical stage product candidates in development. These therapies are enabled by its HelixTM biotherapeutic delivery and Morph® vascular navigation platforms. The CardiAMP Cell Therapy Trial for Heart Failure has been supported financially by the Maryland Stem Cell Research Fund and the Center for Medicare and Medicaid Services. For more information visit: www.BioCardia.com. Forward Looking Statements This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the enrollment in our clinical trials, the availability of data from our clinical trials, filings and communications with the FDA and Japan’s PMDA, product clearances, the efficacy and safety of our products and therapies, the achievement of any of the anticipated upcoming milestones, our positioning for growth or the market for our products and therapies, the expected benefits of our intellectual property, future prospects, regulatory timelines, and other statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Such risks and uncertainties include, among others, the inherent uncertainties associated with developing new products or technologies, regulatory approvals, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardia’s business and product development plans, the ability to enter into licensing and partnering arrangements and overall market conditions. We may find it difficult to enroll patients in our clinical trials due to many factors, some of which are outside of our control. Slower than targeted enrollment could delay completion of our clinical trials and delay or prevent the development of our therapeutic candidates. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 26, 2025, under the caption titled “Risk Factors BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.”  1. Raval AN and Pepine CJ. Clinical Safety Profile of Transendocardial Catheter Injection Systems: A Plea for Uniform Reporting, Cardiovasc Revasc Med, 2021.2. Mitsutake Y, Pyum WB, Rouy D, et al. Improvement of local cell delivery using Helix Transendocardial Delivery Catheter in a porcine heart, Int Heart J. 2017.  BIOCARDIA, INC.             Consolidated Statements of Operations             (Unaudited In thousands, except share and per share amounts)                               Three Months endedJune 30,   Six Months endedJune 30,       2025  2024   2025  2024 Revenue:              Collaboration agreement revenue$— $3  $— $58 Costs and expenses:              Research and development 1,368  800   2,898  2,041  Selling, general and administrative 683  852   1,879  1,941   Total costs and expenses 2,051  1,652   4,777  3,982   Operating loss (2,051) (1,649)  (4,777) (3,924)Other income (expense):               Total other income, net  2  3   16  11 Net loss$(2,049) $(1,646)  $(4,761) $(3,913)                  Net loss per share, basic and diluted$(0.40) $(0.88)  $(0.98) $(2.20)                  Weighted-average shares used in computing             net loss per share, basic and diluted 5,059,736  1,877,069   4,848,922  1,776,305                   BioCardia, Inc.      Selected Balance Sheet Data      (amounts in thousands)               June 30,2025(1)   December 31,2024(1)            Assets:      Cash and cash equivalents$980  $2,371Other current assets 219   251Property, plant and equipment and other noncurrent assets 890   1,102Total assets$2,089  $3,724Liabilities and Stockholders’ Equity (Deficit)      Current liabilities$3,642  $2,321Operating lease liability – noncurrent 333   566Total stockholders’ equity (deficit) (1,886)  837Total liabilities and stockholders’ equity (deficit)$2,089  $3,724       (1) June 30, 2025 amounts are unaudited. December 31, 2024 amounts were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission on March 26, 2025.         Media Contact: Miranda Peto, Investor RelationsEmail: mpeto@BioCardia.comPhone: 650-226-0120 Investor Contact: David McClung, Chief Financial OfficerEmail: investors@BioCardia.comPhone: 650-226-0120

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First LockeT Cases Completed in Germany

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FORT MILL, S.C., Aug. 13, 2025 (GLOBE NEWSWIRE) — Catheter Precision, Inc. (VTAK – NYSE/American), a US based medical device company focused on developing technologically advanced products for the cardiac electrophysiology market announced that the first LockeT cases were recently completed in Germany at Zentralklinik Bad Berka. With a total of 20 clinics and specialist departments, it is one of the largest hospitals in Thuringia.

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Eko Health Expands Clinical Advisory Board to Advance AI-Powered Disease Detection

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Expansion brings together top clinical leaders to help scale Eko’s disease detection platform following major FDA clearances, reimbursement wins, and peer-reviewed publications SAN FRANCISCO, Aug. 6, 2025 /PRNewswire/ — Eko Health, a leader in AI-powered cardiac and pulmonary care, announced the expansion of its Clinical Advisory Board to support the company’s mission […]

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BiVACOR Total Artificial Heart Accepted into FDA’s Total Product Life Cycle (TAP) Program

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Milestone Deepens Strategic Partnership with FDA Following Breakthrough Device Designation HUNTINGTON BEACH, Calif.–(BUSINESS WIRE)–BiVACOR, Inc., a clinical-stage medical device company developing the world’s first titanium Total Artificial Heart (TAH), today announced that its TAH System has been accepted into the U.S. Food and Drug Administration’s (FDA) prestigious Total Product Life […]

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Merit Medical Launches the Prelude Wave Hydrophilic Sheath Introducer with SnapFix Technology

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Thin-wall design with superior insertion and unique sheath-securement solution to support successful radial access procedures and may aid in reducing arterial spasm and occlusionSOUTH JORDAN, Utah, Aug. 07, 2025 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, today announced the US commercial release of the Prelude Wave™ Hydrophilic Sheath Introducer with SnapFix™ Securement Technology. The Prelude Wave is the latest innovation in Merit’s comprehensive Access portfolio, which includes a wide range of dilators, micro-access systems, sheath introducers, and guide sheaths. A low-profile, hydrophilic sheath with best-in-class insertion and sheath retention, the Prelude Wave with SnapFix technology is designed with features which may aid in the reduction of arterial spasm and occlusion as physicians perform radial access procedures. Radial access offers many well-documented benefits compared to the femoral approach,1 but there remain opportunities to improve patient outcomes, as radial artery spasm (narrowing) and occlusion (blockage) can still occur. Radial artery spasm is reported in up to 20% of patients,2 and approximately 4.6% will have a radial artery occlusion,3 both of which can lead to patient discomfort and other complications.4,5 Sheath features, such as a hydrophilic coating, a low profile, and tapered transitions have been shown to help reduce the risks of radial artery spasm and occlusion as well as improve patient comfort.1,6 In addition, securement devices utilized to stabilize hydrophilic sheaths during procedures have been linked to reported issues in 30% of cases, leading to procedural inefficiency.7 A securement device specifically developed for sheaths may help alleviate the challenges physicians face. To meet these clinical needs, Merit innovated the Prelude Wave, a next-generation sheath with a unique securement feature. Compared to the leading competitor, the Prelude Wave offers twice the lubricity, twice the resistance to buckling and kinking, and requires 40% less insertion force.8 A first of its kind, SnapFix technology provides twice the adhesive strength, with physicians rating its performance and ease of use superior to the leading competitor.8 Learn more about the Prelude Wave with SnapFix Technology. “Prelude Wave addresses challenges interventionalists see when performing radial procedures,” said Morton Kern, MD, MSCAI, FACC, FAHA, Interventional Cardiologist at Veterans Administration Long Beach Health Care System in Long Beach, CA, and a consultant of Merit. “A sheath and securement solution that may help minimize these risks, while also offering strong radial access performance, provides physicians with a meaningful product option that creates a better treatment experience for patients.” To further support a radial-first approach, Merit has tailored its portfolio with solutions that complement existing products, designed to address physicians’ toughest clinical challenges. A recent example of this was Merit’s acquisition of StatSeal®, a patented hemostatic sealant used to protect access sites, as seen in radial procedures. “Whether by design or acquisition, we always strive to advance innovation in our Access portfolio, providing our healthcare partners with solutions that support data-driven approaches to treatment,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “The Prelude Wave with SnapFix Technology is a superior product built to champion radial procedures, manufactured with features designed to aid in minimizing common vascular access challenges. We’re proud to continue offering radial technology advancements for physicians and their patients.” ABOUT MERIT MEDICAL Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling more than 800 individuals. Merit employs approximately 7,300 people worldwide. TRADEMARKS Unless noted otherwise, trademarks and registered trademarks used in this release are the property of Merit Medical Systems, Inc., its subsidiaries, or its licensors. Any forward-looking statements set forth in this release are subject to risks and uncertainties such as those described in Merit’s filings with the U. S. Securities and Exchange Commission (“SEC”). For a further discussion of the risks and uncertainties which may affect Merit’s business, operations and financial condition, see Part I, Item 1A, “Risk Factors” in Merit’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC, Part II, Item 1A, “Risk Factors” in Merit’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025 filed with the SEC and Merit’s other filings with the SEC. Actual results will likely differ, and may differ materially, from anticipated results. CONTACTS PR/Media InquiriesSarah ComstockMerit Medical+1-801-432-2864 | sarah.comstock@merit.com  INVESTOR INQUIRIES Mike Piccinino, CFA, IRCWestwicke – ICR+1-443-213-0509 | mike.piccinino@westwicke.com References Rathore et al. 2010. “Impact of Length and Hydrophilic Coating of the Introducer Sheath on Radial Artery Spasm during Transradial Coronary Intervention.” JACC Cardiovasc Interv 3, no. 5 (May): 475 ̶ 83. doi: 10.1016/j.jcin.2010.03.009.Randall and Boudoulas. “Reducing Radial Spasm.” Society for Cardiovascular Angiography & Interventions (2024 Sep 19).Pitta, Sharma, and Boudoulas. “Newer Emerging Strategies to Reduce Radial Artery Occlusion: Post-Transradial Catheterization.” Society for Cardiovascular Angiography & Interventions (2025 Jun 19).Zus et al. 2024. “Radial Artery Spasm—A Review on Incidence, Prevention and Treatment.” Diagnostics (Basal) 14, no 17 (Aug 29): 1897. doi: 10.3390/diagnostics14171897.Tsigkas et al. 2023. “Preventing and Managing Radial Artery Occlusion Following Transradial Procedures: Strategies and Considerations.” J Cardiovasc. Dev Dis. 10, no. 7 (Jun 30): 283. doi: 10.3390/jcdd10070283.Mason et al. 2018. “An Update on Radial Artery Access and Best Practices for Transradial Coronary Angiography and Intervention in Acute Coronary Syndrome: A Scientific Statement from the American Heart Association.” Cir Cardiovasc Interv 11, no. 9 (Sept): e000035. doi: 10.1161/HCV.0000000000000035.Kern et al. 2020. “Securing the Radial Sheath: An Update on a Pesky but Persistent Little Problem.” Cath Lab Digest (Nov).Data on File.

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BDC Laboratories Partners with Newly Launched Dilawri Cardiovascular Institute to Advance Clinically Relevant Cardiovascular Device Testing

Coronary/Structural Heart by Comments are Disabled

Strategic collaboration supports cutting-edge translational research, combining regulatory-grade bench testing with clinical insight to improve outcomes for patients. WHEAT RIDGE, Colo. and VANCOUVER, BC, Aug. 7, 2025 /PRNewswire/ — BDC Laboratories, a leader in cardiovascular device…

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